IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry (IVTCC)
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|ClinicalTrials.gov Identifier: NCT04520347|
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2020
Last Update Posted : April 1, 2021
|Condition or disease|
|Ventricular Arrhythmia Ventricular Tachycardia Premature Ventricular Contraction (PVC) Cardiomyopathy|
Sudden cardiac death (SCD), predominantly due to ventricular tachyarrhythmias, is a leading cause of mortality in the United States and around the world. Catheter ablation of ventricular arrhythmias has proven efficacious in reducing the burden of arrhythmias and reducing implantable cardiac defibrillator (ICD) shocks.
The aim of this study is to create a prospective international database registry that will allow for better assessment of the outcomes of catheter ablation of ventricular arrhythmias. The registry, with approximately 30 participating centers, will help to identify the overall success rates and associated benefits of the procedure and provide more comprehensive data on understudied populations and treatment.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||An International VT Ablation Center Collaborative Group (IVTCC): A Multicenter Ventricular Tachycardia Catheter Ablation Registry|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 2026|
|Estimated Study Completion Date :||November 2027|
- Ventricular tachycardia (VT) recurrence [ Time Frame: From date of procedure assessed by shock, Anti-Tachycardia Pacing, or repeat procedure, up to 10 years. ]Freedom from ventricular tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing) or repeat procedure.
- Rate of complications [ Time Frame: From date of procedure assessed up to 12 months. ]Cardiovascular-related and procedure-related major complications and/or adverse events.
- Time to transplant or death [ Time Frame: From date of procedure assessed by date of transplant and/or death, up to 10 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520347
|Principal Investigator:||Jason Bradfield, MD||University of California, Los Angeles|
|Study Chair:||Kalyanam Shivkumar, MD, PhD||University of California, Los Angeles|
|Study Chair:||Paolo Della Bella, MD||San Raffaele Hospital, Italy|
|Study Chair:||Francis Marchlinski, MD, FACC, FAHA, FHRS||University of Pennsylvania Health System|
|Study Chair:||Andrea Natale, MD, FACC, FHRS, FESC||Texas Cardiac Arrhythmia Institute at St. David's Medical Center|
|Study Chair:||William G Stevenson, MD||Vanderbilt Heart and Vascular Institute|